FDA Throws More Cold Water On Amarin’s Hopes For Vascepa

Any remaining hopes for an expanded indication for Amarin’s Vascepa were largely dashed today by the FDA. Although it hasn’t yet rejected the proposed indication, the FDA today essentially overturned the foundation of the application, leaving little doubt as to the ultimate fate of the proposed new indication. As veteran biotechnology reporter Adam Feuerstein tweeted:

“The chance of FDA approval for Anchor went from 0.00000001% to 0.00000000001%.”

Click here to read the full post on Forbes.


And The Fat Lady Sings


  1. […] analogy to help understand the way IMPROVE-IT could impact the fate of the PCSK9 inhibitors. Just recently supporters of Amarin’s fish oil pill Vascepa thought the drug would coast to approval for a […]

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